The pharmaceutical industry, hospitals, care centers, laboratories and similar industries and facilities are constantly struggling against contaminations such as bacterial infections and viral infections. Hygiene issues are constantly on the topic and continuously evaluated. One hygiene issue of special character is the washing, disinfecting and sterilization of goods, such as sterilizing medical, dental, laboratory and/or pharmaceutical goods. The goods may be reusable goods or disposable goods.
Reusable goods used on such facilities can be surgical equipment such as knifes, graspers, clamps, retractors, dilators, probes, scopes, drills, and saws, laboratory equipment such as bottles, bowls, condensers, funnels, flasks, pipettes and plates, or the like. Any object which is intended to be reused and which can be contaminated with hazardous or biological substances is the subject of harsh hygiene conditions. Whenever reusable goods have been used, such as reusable medical equipment, the reusable goods are sent for washing, disinfecting and/or sterilization.
The process of washing, disinfecting and sterilizing goods, such as reusable medical equipment mentioned above, is a very high demanding process in terms of the rules and regulations, facilities used, the staff, the process parameters, the apparatuses and even the ambient environment surrounding the apparatuses. All restrictions and conditions serving the purpose to reduce, or eliminate, the risk for contamination makes it difficult and costly to operate washing, disinfecting and/or sterilizing processes.
For example, a pharmaceutical production site may be equipped with steam generators, water pretreatment apparatuses, Closure processing systems, discharge systems, component washers, glassware washers, component sterilizer, terminal sterilization systems, isolators and sterility testing equipment, simply to clean and sterilize different reusable medical equipment. The cleaning and the sterilizing apparatuses are further usually separated in different environmental zones, each environmental zone having its own environmental conditions imposed thereon. Such environmental conditions can be demands on humidity, temperature, air pressure, ventilation systems, and access to clean water, or the like.
Examples of different environmental areas, or zones, in which the environmental conditions can vary are distribution areas, reception areas, clean areas and sterile areas. Each area is generally separated by a zone barrier. A zone barrier can be a physical wall which is keeping an air pressure differential, and can sometimes be referred to as a cross-contamination wall. A cross-contamination wall can be air sealed and adapted to physically prevent staff members from moving between the environmental areas and air to travel there between. All precautionary measures are thus taken to prevent cross contamination between the environmental areas.
Some cleaning devices, such as sterilizers for example, may be of a pass-through model. A pass-through sterilizer extends across a zone barrier and permits a staff member to load goods at one end of the sterilizer and unload sterilized goods at the other end. The sterilizer thus extends across at least one zone barrier.
The harsh hygiene conditions imposed on each environmental area, the zone barriers between the environmental areas, and the limited freedom of movement between the environmental areas for the staff members, impose high demands on the apparatuses and washing, disinfection and sterilization processes used therein.
To secure that the goods is properly treated, cleaned, disinfected or sterilized, the staff member may be required to check the track record, also referred to as batch or process record. Track records are recorded by separate computers or printers and are inspected using a graph in analog or in digital form. The staff member usually also has to make an ocular inspection of the goods to secure that the goods is in good condition and not for example wet or damaged. When these inspections have been successfully carried out, the staff member prints out a track record and sign it. The track record is thereafter put in a folder and filed. However, there is nothing that stops the staff member from releasing the sterilized goods earlier before these inspections have been carried out.
There is a possibility that due to human mistakes the goods can be unloaded and released from the sterilizer without being formally approved. If the sterilized goods are not inspected there is a risk that errors or faults in the sterilization process are not discovered. Furthermore, if a formal approval is missing, it is a clear indication that the inspection has not been successfully or appropriately carried out. This could have severe consequences causing non sterile or contaminated medical, dental, laboratory and/or pharmaceutical goods to be released.
There is thus a need to simplify the formal approving process of a batch before releasing the batch from the sterilizer. There is also a need to improve the sterilizing apparatus to prevent non sterile medical, dental, laboratory and/or pharmaceutical goods to be accidentally or incorrectly released.